Colostomy is the surgical procedure of making an opening from the colon to the outside of the abdomen. In a colostomy, the surgeon may remove a segment of the colon, resulting in the colon being split into two separate parts. One end of the colon is passed through a small hole in the abdominal wall. This section of intestine called a stoma, allows for body waste to leave the body from the colon. The other end of the colon, which is attached to the rectum, may either be removed or closed off with sutures and left in the abdomen. There are other similar stoma operations such as ileostomy which is a stoma from the small intestine, and urostomy which is a stoma from the urinary system. Operations are performed for temporary or permanent stomas. Such operations are performed on humans and animals as well. In all cases, stoma wafers are used which are adhesive skin barriers or skin flanges with a fitted orifice at the center to allow the stoma to protrude. These stoma wafers consist of either a one piece wafer and bag or a two piece wafer with a snap-on or similar coupling for attaching the bag to the wafer. The bags are also known as pouches in the ostomy field. The bags clamp to a wafer by a coupling to retain the body waste discharged by the stoma. A major concern is the leaking of mucous and body wastes onto the skin surrounding the stoma. Generally ostomy wafers are produced with an orifice fitting as perfectly as possible around a stoma and held into position by adhesive. The adhesive generally covers the complete under surface of the ostomy wafer to secure against leakage for as long as the adhesive holds. The ostomy wafer is impermeable and must not lift around the stoma. The mucous and body waste irritate the skin around a stoma because of the low pH. Prolonged exposure of the low pH causes severe complications to the point of requiring surgery. All ostomy adhesive wafers invented and patented concentrate on leakage as the primary issue. Certain ostomy adhesive wafers have been invented with a central insert in the form of a removable Insert with a tacky adhesive backing in order to be able to remove it, wash it and reuse it, while still attaining the waterproof seal required until the adhesion is no longer sufficient to hold the appliance in place. Others have invented central inserts with specific shapes, in the form of a convex disc in order to try to improve the sealing efficiency. Such is the case with the following U.S. patents listed from A) to F).    A) Apr. 3, 2001, the U.S. patent U.S. Pat. No. 6,210,384 B1 that has a convex insert of a considerable thickness greater than 1/16 inch whereby the under surface of the wafer is totally covered with adhesive with the exception of the skin surface under the convex insert that contacts the skin around the stoma. The surface exposed without adhesive is less than ¼ inch from the stoma. This surface is not sufficiently distanced from a stoma to prevent traumatizing the skin by adhesives and to prevent leaks due to the lifting of the wafer from lack of adhesion.    B) Feb. 6, 2007, the U.S. patent U.S. Pat. No. 7,172,581 B2 that is an adhesive wafer that has an insert in the form of a sealing disc that adheres by adhesion using adhesives. Therefore once again the under surface of the initial wafer and the insert cover the entire surface with adhesive, thus encountering the same complications of use and side effects as the U.S. patent U.S. Pat. No. 6,210,384 B1 described as item A) of this “Background of the invention” section of the present patent.    C) Sep. 9, 2008, the U.S. patent U.S. Pat. No. 7,422,578 B2 that has a fitted wafer with a coupling connecting the wafer to a detachable ostomy pouch. The wafer used again covers the entire under surface of the adhesive wafer that is in direct contact with the skin around a stoma.    D) Jan. 11, 2011, the U.S. Pat. No. 8,684,982 B2 that has several flangible bridges or annular shaped connections or adhesive type couplings attaching one to the other, however, once again the entire under surface of the appliance is covered with adhesive.    E) Apr. 8, 2014, the U.S. patent U.S. Pat. No. 8,690,848 B2 that has an elaborate ostomy closure for sealing an ostomy pouch consisting of an adhesive wafer with a plate orifice resembling the coupling wafer of the present invention, however, once again this apparatus has adhesive on the entire under surface of the initial layer that is exposed to the skin around a stoma.    F) Jul. 1, 2014, the U.S. patent U.S. Pat. No. 8,764,717 B2 that has an adhesive wafer with inner periphery surrounding the stoma of elastomeric material with a coupling to attach or receive a corresponding coupling ring arranged on an ostomy coupling bag.
In all the cases of inserts or center pieces described in the patents listed from A) to F) in the present patent “Background of the invention” section, adhesive substances cover the under surface of the wafers from ¼ inch starting from the base of a stoma to the exterior periphery of the ostomy wafers. In other cases solid hard inserts thicker than ⅛ inch are inserted around a stoma. The key reason for keeping the adhesive wafers close to the base of a stoma is to cover the skin surface around a stoma with a waterproof impermeable substance that must be prevented from lifting. The key reason for solid hard inserts around a stoma is to try to create a better seal with specific shapes such as convex inserts around low profile or below the skin concave stomas.
The present invention is for an ostomy wafer appliance and method of securing around a stoma a thin central impermeable waterproof membrane, that is less than 1/16 inch thick with a central fitted stoma size orifice, which membrane is on an annular coupling that attaches and detaches by a coupling mechanism from an opposite corresponding male or female coupling on the inner upper periphery of an ostomy adhesive wafer fabric membrane skirt. An ostomy pouch or other body waste or mucous collecting appliance attaches by way of piggyback or superimposition onto the annular coupling with a similar opposite corresponding male or female coupling of the waterproof membrane and coupling assembly
The appliance consists of an annular adhesive wafer fabric membrane skirt from inch to several inches wide with the center that is void. The said annular adhesive wafer fabric membrane skirt has adhesive on the complete undersurface. The said void is two (2) to four (4) times or more the diameter of the said stoma. The said annular adhesive wafer fabric membrane skirt is adhered to the skin around the said stoma by the said adhesive. The said annular adhesive wafer fabric membrane skirt has an annular coupling at the upper inner periphery of the said annular adhesive fabric membrane skirt. The said annular coupling is mechanically connected to an opposite corresponding male or female connecting annular coupling that is equipped with a sealing membrane on its inner annular periphery.
The said sealing membrane is less than 1/16 inch in thickness, is waterproof, pliable, malleable, has elastic properties and has a central orifice equal to or smaller than the stoma it is being applied to. The said sealing membrane covers the complete said void. The under surface of the said sealing membrane will not have adhesive. Instead, the under surface of the said sealing membrane will be void having nothing or there will be beneficial substitutes added as required such as fillers, gels, or creams.
The upper surface of the said opposite corresponding annular coupling is formed and shaped to mechanically superimpose and connect by way of piggyback or superimposition with an exact replica, duplicate, double of the said opposite corresponding annular coupling. The annular couplings will hold together mechanically by way of piggyback or superimposition at the upper surface of the said opposite corresponding annular coupling. The said exact replica of the said opposite corresponding annular coupling will be equipped with an ostomy pouch or other body waste or mucous collecting appliance that is attached at the inner periphery of the said exact replica annular coupling. The said exact replica annular coupling may also be used with a throw-away or a non-throw-away liner or pouch that is mechanically squeezed, clamped, in position between the said opposite corresponding annular coupling and the said exact replica of the said opposite corresponding annular coupling.